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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH DURASUL, ALPHA INSERT, HOODED, KK/32 N/A

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ZIMMER GMBH DURASUL, ALPHA INSERT, HOODED, KK/32 N/A Back to Search Results
Model Number N/A
Device Problem Disassembly
Event Date 05/24/2018
Event Type  Malfunction  
Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The device manufacturing quality records indicate that the released components met all requirements to perform as intended. An e-mail requesting the following additional information was sent on (b)(6) 2018 to the appropriate representatives. This product is manufactured by zimmer biomet (b)(6) and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states under 510(k) number k993259. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. (b)(4).

 
Event Description

It was reported that during a surgery the durasul, alpha insert, hooded, kk/32 did not fit into the cup. Surgery was completed with another inlay. No surgical delay has been reported.

 
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Brand NameDURASUL, ALPHA INSERT, HOODED, KK/32
Type of DeviceN/A
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7604940
Report Number0009613350-2018-00630
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number01.00013.511
Device LOT Number2932416
OTHER Device ID Number00889024507609
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/27/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/08/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/15/2018 Patient Sequence Number: 1
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